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Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs

NCT ID: NCT02327832

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Brief Summary

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Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is \<3.0 mg/dL, patients who are still deemed unsuitable as a candidate for general anesthesia. About 30 mL of autologous bone marrow was collected from the bilateral iliac crests under local anesthesia, heparin was added after collection. In addition, at the Center for Regenerative and Cell Therapy at Yamaguchi University Hospital, a nucleated cell fraction was prepared. Next, a cell suspension was prepared by adding culture medium, and this was inoculated into a culture flask. After subculturing for 3 weeks, the cells were infused through a peripheral vein. The primary endpoint is the incidence of adverse events up to 24 weeks after ABMSC infusion.

Detailed Description

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Conditions

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Liver Regeneration

Keywords

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Confirmation safety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous BMSCs

Infusion of cultured autologous bone marrow derived mesenchymal stem cells

Group Type EXPERIMENTAL

Autologous BMSCs

Intervention Type PROCEDURE

Cultured autologous bone marrow-derived mesenchymal stem cells

bone marrow-derived mesenchymal stem cells

Intervention Type DRUG

Interventions

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Autologous BMSCs

Cultured autologous bone marrow-derived mesenchymal stem cells

Intervention Type PROCEDURE

bone marrow-derived mesenchymal stem cells

Intervention Type DRUG

Other Intervention Names

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BMSC

Eligibility Criteria

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Inclusion Criteria

* Patients who are still deemed unsuitable as a candidate for general anesthesia.
* Patients must provide informed consent for study participation.

Exclusion Criteria

* Patients with a current history of malignant neoplasm.
* Patients with gastroesophageal varices at risk of rupture.
* Patients with renal insufficiency and a serum creatinine ≥2 mg/dL.
* Patients with a hemoglobin \<8 g/dL, a platelet count \<50,000/μL, or a prothrombin time \<40%.
* Patients with a performance status of 3 or 4.
* Patients who refuse to consent to allogeneic blood transfusion.
* Women who are pregnant.
* Patients whom their attending physician deems are not suitable candidates for general anesthesia.
* Patients with a current or previous severe allergic reaction to a contrast agent, beef, cow milk, and anesthesia.
* Any patient deemed unsuitable for study inclusion by their attending physician.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yamaguchi University Hospital

OTHER

Sponsor Role lead

Responsible Party

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tarotakami

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Isao Sakaida, MD, PhD

Role: STUDY_CHAIR

Yamaguchi University Hospital

Locations

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Department of Gastroenterology and Hepatology Yamaguchi University Graduate School of Medicine

Ube, Yamaguchi, Yamaguchi, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Taro Takami, MD, PhD

Role: CONTACT

Phone: +81836222241

Email: [email protected]

Facility Contacts

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Taro Takami, MD, PhD

Role: primary

Other Identifiers

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ICHINAI-BMSC1

Identifier Type: -

Identifier Source: org_study_id